U.S. PHARMACOPEIA

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Ampicillin for Oral Suspension
» Ampicillin for Oral Suspension contains an amount of Ampicillin (anhydrous or as the trihydrate) equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C16H19N3O4S, when constituted as directed. It contains one or more suitable buffers, colors, flavors, preservatives, and sweetening ingredients.
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate whether the ampicillin therein is in the anhydrous form or is the trihydrate.
Identification— Dissolve a quantity in a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing 5 mg of ampicillin per mL: the resulting solution responds to the Identification test under Ampicillin Capsules.
Uniformity of dosage units 905—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 7.5, in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 2.5%, or not more than 5.0% if it contains ampicillin trihydrate and contains the equivalent of 100 mg of ampicillin per mL when constituted as directed in the labeling.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Standard preparation— Prepare as directed for Standard Preparation under Iodometric Assay—Antibiotics 425, using USP Ampicillin RS.
Assay preparation— Dilute an accurately measured volume of Ampicillin for Oral Suspension, constituted as directed in the labeling, freshly mixed and free from air bubbles, quantitatively and stepwise with water to obtain a solution containing about 1.25 mg of ampicillin per mL.
Procedure— Proceed as directed for Procedure under Iodometric Assay—Antibiotics 425. Calculate the quantity, in mg, of C16H19N3O4S in each mL of the constituted suspension prepared from Ampicillin for Oral Suspension taken by the formula:
(T / D)(F / 2000)(B I),
in which T is the labeled quantity, in mg per mL, of ampicillin in the constituted suspension; and D is the concentration, in mg per mL, of ampicillin in the Assay preparation on the basis of the labeled quantity in the constituted suspension and the extent of dilution.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 168
Phone Number : 1-301-816-8223